Eligibility NCT00641056 Type 2 Diabetes Mellitus Inclusion Criteria Exclusion Criteria Have had a clinically significant history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty. or is expected to require coronary artery bypass surgery or angioplasty during the course of the study. Yes
No
Have clinical signs or symptoms of liver disease, acute or chronic hepatitis. Yes
No
Have a history of renal transplantation or are currently receiving renal dialysis. Yes
No
Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years. Yes
No
Have had > 3 episodes of major hypoglycemia within 6 months prior to screening. Yes
No
Have any contraindication for the oral antidiabetic agent which they use. Yes
No
Have a known allergy or hypersensitivity to insulin glargine, exenatide once weekly, or excipients contained in these agents. Yes
No
Are known to have active proliferative retinopathy. Yes
No
Have been treated with drugs that promote weight loss (e.g., Xenical [orlistat], Meridia [sibutramine], Acomplia [rimonabant], Acutrim [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening. Yes
No
Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: Yes
No
Insulin, regular insulin Yes
No
Thiazolidinediones (e.g., Actos [pioglitazone] or Avandia [rosiglitazone]) Yes
No
Alpha-glucosidase inhibitors (e.g., Glyset [miglitol] or Precose [acarbose]) Yes
No
Meglitinides (e.g., Prandin [repaglinide] or Starlix [nateglinide]). Yes
No
Byetta (exenatide BID formulation) Yes
No
Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia [sitagliptin], Galvus [vildagliptin]) Yes
No
Symlin, Pramlintide Acetate Yes
No
Organ Transplantation, Organ Transplant Yes
No
Have donated blood within 30 days of screening. Yes
No
Have previously completed or withdrawn from this study or any other study investigating exenatide once weekly. Yes
No
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. Yes
No
Are currently enrolled in any other clinical study. Yes
No
